Enanta Pharmaceuticals Inc. (ENTA, Financial) announced on Monday the results of the Phase 3 CERTAIN-1 study done in collaboration with AbbVie (ABBV, Financial) that assessed the safety and efficacy of AbbVie’s investigational regimen of glecaprevir/pibrentasvir (G/P) in Japanese patients infected with genotype 1 chronic hepatitis C virus without cirrhosis.
The structure of the study was based on the presence of a genetic mutation of the virus called Y93H. Patients with a Y93H genetic mutation of the virus are resistant to nucleotide NS5B inhibitors (pibrentasvir). Participants were treated based on the presence of the mutation.
Out of 106 patients who do not have the Y93H variant, the RNA of the virus was undectable in the blood serum of 105 participants 12 weeks after treatment. The remaining participant did not complete the study. The company said patients were treated for either eight weeks with G/P or for 12 weeks with Viekirax.
In the blood serum of all 23 non-cirrhotic patients with a Y93H variant of the hepatitis C virus, the RNA of the virus was undetectable 12 weeks after the treatment. The company said these patients received an eight-week treatment of G/P.
Compared to an earlier study in which the totality of 52 patients chronically infected with genotype 1 hepatitis C virus achieved SVR12 after a 12-week period of treatment with Viekirax, the CERTAIN-1 study showed to be equivalent in terms of safety and efficacy.
According to Entana, “Japan has one of the highest rates of hepatitis C infection in the industrialized world affecting approximately 1 million people, 60 to 70 percent of those are GT1.”
In 2016, Enanta reported a 45.12% decrease in revenues, mainly due to a 76% decrease in milestone payments. It also reported a 72.53% decrease in the bottom line, mainly due to higher research and development expenses than those sustained in 2015 (up 74% on a year over year basis).
In 2016, Enanta Pharmaceuticals realized $30 million versus $125 million received in 2015 for collaborations with AbbVie.
As of the fourth quarter, the company had $242.2 million in cash on hand and securities to be converted into cash. The company said this will be sufficient to meet the anticipated cash requirements of its existing business for the foreseeable future.
Enanta closed at $35.46 per share on Tuesday, down 28 cents or -0.78% from the previous trading day, with a volume of 160,183 shares traded on Nasdaq. The stock hit a new high on Jan. 6 and the 52-week range is now between $20.39 per share and $37.31 per share.
The stock is less volatile than the market with a beta of 0.69.
Enanta has a market capitalization of $675.12 million and has 19.04 million shares outstanding. Insiders hold 24.7% of shares outstanding and institutional ownership is 78.40%.
The number of shares available for trading is 13.08 million. The price-earnings (P/E) ratio is 31.38 and the EPS (TTM) is $1.13.
AbbVie is trading around $63.43 per share on the New York Stock Exchange and outperformed the S&P 500 by 1.02% year to date.
Disclosure: I have no position in AbbVie.
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